Table 2b. FF plasma PK summary in study 2 (200587).
| Parameter | Treatmenta | N | n | Geometric mean (95% CI) |
%CVb |
|---|---|---|---|---|---|
| AUC(0–4) (h×pg/mL) | FF/UMEC(500)/VI | 44 | 44 | 212 (196 – 229) | 26.0 |
| FF/UMEC(250)/VI | 43 | 43 | 211 (192 – 232) | 31.8 | |
| FF/VI | 43 | 43 | 219 (200 – 239) | 29.6 | |
| AUC(0–t) (h×pg/mL) | FF/UMEC(500)/VI | 44 | 44 | 629 (555 – 713) | 43.2 |
| FF/UMEC(250)/VI | 43 | 43 | 607 (525 – 702) | 49.9 | |
| FF/VI | 43 | 43 | 644 (566 – 732) | 43.8 | |
| Cmax (pg/mL) | FF/UMEC(500)/VI | 44 | 44 | 81.4 81.5 (73.3 – 90.6) | 35.9 |
| FF/UMEC(250)/VI | 43 | 43 | 81.1 (72.2 – 91.0 91.1) | 39.1 | |
| FF/VI | 43 | 43 | 85.7 (76.6 – 95.8) | 37.6 | |
| tmax (h)b | FF/UMEC(500)/VI | 44 | 44 | 0.2 0.3 (< 0.1, 2.0) | NA |
| FF/UMEC(250)/VI | 43 | 43 | 0.2 0.3 (< 0.1, 2.0) | NA | |
| FF/VI | 43 | 43 | 0.2 (< 0.1, 2.0) | NA | |
| tlast (h)b | FF/UMEC(500)/VI | 44 | 44 | 24.0 (4.0, 24.1) | NA |
| FF/UMEC(250)/VI | 43 | 43 | 24.0 (8.0 6.0, 24.1) | NA | |
| FF/VI | 43 | 43 | 24.0 (8.0, 24.1) | NA |
aTotal dose as 4 consecutive doses: 400 μg FF, 500 μg or 250 μg UMEC, and 100 μg VI. bMedian (min, max).